Year Ended March 31, 2018 Corporate Communications Group Tel: +81-6-4802-9360 Fax: +81-6-6359-3827 E-mail: ir@santen.com Stock Code: 4536
Contents Financial highlights Consolidated financial summary 2 Consolidated balance sheets summary 2 Consolidated financial indexes 2 Exchange rates 2 Consolidated information Consolidated statements of income and comprehensive income ( and Core basis) 4 Consolidated statements of income and comprehensive income () 5 Net sales/revenue details 6 Net sales/revenue by business segment 6 Overseas net sales/revenue by region 6 Overseas profit contribution 6 Net Sales/Revenue of major pharmaceuticals 7 Consolidated statement of financial position 8 Assets 8 Equity and liabilities 8 Consolidated statements of cash flows 9 Other consolidated information 10 R&D expenses 10 Capital expenditures 10 Depreciation and amortization 10 Amortization on intangible assets associated with products 10 Additional information of statement of financial position 10 Number of employees 10 Reference information Research & development 11 Pipeline of prescription pharmaceuticals (Clinical stage) 11 Changes from Q3 FY17 (February 6, 2018) 12 Pharmaceutical market in Japan 13 Revision of National Health Insurance (NHI) drug prices 13 Market shares in prescription ophthalmics 13 Market shares by therapeutic area - prescription ophthalmics 13 Stock information 14 Stock price (Tokyo Securities Exchange 1st market) 14 Major shareholders (top 10) 14 Major stock information 14 Breakdown of shareholding by number of shares 15 Breakdown of shareholding by number of shareholders 15 Consolidated subsidiaries 16 News releases 17 Santen group has unified the accounting period from the fiscal year ended March 31, 2014, for voluntary adoption of International Financial Reporting Standards () from the fiscal year ending March 31, 2015. In this data book, performance for the unification of accounting period is noted as (*), and financial results for the previous 12 month period are shown as [12month]. Financial results before the fiscal year ended March 31, 2013 are based on the previous 12 month performance. Results contained in the column marked 2014[12month] provide precise and comparable 12 month results including for subsidiaries using different fiscal year periods. The company implemented a 5-for-1 stock split on April 1, 2015. Figures in the column 2014.3[] are adjusted assuming the new, post-split number of shares for comparison purposes. s in this report are based on the currently available information. s in this report are based on the currently available information. Actual results may differ materially depending on a number of factors including adverse economic conditions etc. Actual results may differ materially depending on a number of factors including adverse economic conditions, delays in new products launch, currency exchange rate, legislative and regulatory developments. - 1 -
Financial highlights Consolidated financial summary Year ended March 31 2014* 2014 2015 2016 2017 2018 % Change Net sales/revenue 148,663 146,260 161,831 195,291 199,096 224,942 13.0 237,000 Operating income/profit 27,414 29,878 35,374 80,180 32,479 38,691 19.1 40,700 Net income/net profit for the year 17,109 19,718 24,032 53,373 21,724 35,261 62.3 30,400 Dividends per share (yen) # 20 20 22 25 26 26 0.0 26 Dividend payout ratio (%) 48.2 41.9 37.8 19.4 49.1 30.0 (38.9) 34.6 Notes: The company implemented a 5-for-1 stock split on April 1, 2015. Dividends per share have been retrospectively adujusted to reflect the impact of the share split.. Core operating profit - 30,403 39,088 43,067 39,687 45,378 14.3 48,000 Core net profit for the year - 19,813 25,948 29,163 29,125 33,458 14.9 35,300 Consolidated statement of financial position summary Year ended March 31 2014* 2014 2015 2016 2017 2018 % Change Total assets 231,105 237,640 304,200 355,399 358,906 388,463 8.2 Total equity 181,209 187,210 211,779 260,009 255,929 287,557 12.4 Interest-bearing debt 110 153 37,161 22,484 16,963 7,618 (55.1) Consolidated financial indexes Year ended March 31 2014* 2014 [12month] 2014 2015 2016 2017 2018 % Change EPS (yen) 207.29 229.26 47.78 58.18 128.99 52.96 86.73 63.8 BPS (yen) #1 2,189.50 2,234.70 452.43 511.14 627.78 628.09 702.54 11.9 Debt equity ratio (times) 0.0 0.0 0.0 0.2 0.1 0.1 0.0 (60.1) PER (times) 22.1 20.0 19.2 30.1 13.1 30.4 19.8 (34.9) PBR (times) 2.1 2.1 2.0 3.4 2.7 2.6 2.4 (4.9) ROE (%) #1 9.9 10.8 11.1 12.0 22.6 8.4 13.0 54.5 ROA (%) 7.9 8.8 8.9 8.9 16.2 6.1 9.4 55.1 Equity ratio(%) #1 78.2 79.3 78.8 69.6 73.2 71.1 73.6 3.5 Free cash flows (millions of yen) #2 21,172-20,807 (41,054) 13,433 1,342 32,906 2,351.1 EBITDA (millions of yen) #3 29,812-22,565 22,660 38,596 42,832 49,718 16.1 #1 BPS (equity per share), ROE (return on equity) and equity ratios are based on the inputs of equity per share attributable to owners of the company, net profit attributable to owners of the company, Core net profit attributable to owners of the company and equity attributable to owners of the company ratio. #2 Free cash flows = (Net cash flows from operating activities)-(capital expenditures/payments for acquisition of property, plant and equipment, and intangible assets) #3 EBITDA = : (Income before income taxes) + (Interest expense) + (Depreciation and amortization) Exchange rates : (Core profit for the year) + (Interest expense) + (Depreciation and amortization) Year ended March 31 2014* 2014 2015 2016 2017 2018 [12month] Exchange rate: US dollar 100.04 100.04 110.14 120.45 108.64 110.94 110.00 : Euro 132.98 132.34 139.01 132.46 118.96 129.92 130.00 : CNY 15.93 15.72 17.84 19.05 16.14 16.84 17.00 (Yen) - 2 -
Financial highlights Consolidated Financial summary (Graph) - 3 -
Consolidated statements of income and comprehensive income Year ended March 31 2015 2016 2017 2018 % Change 2018/2017 Revenue 161,831 195,291 199,096 224,942 13.0 Cost of sales (56,373) (72,829) (74,966) (86,378) 15.2 (Percent of revenue) 34.8% 37.3% 37.7% 38.4% - Gross profit 105,458 122,463 124,130 138,564 11.6 (Percent of revenue) 65.2% 62.7% 62.3% 61.6% - Selling, general and administrative expenses (48,893) (59,406) (62,193) (68,788) 10.6 (Percent of revenue) 30.2% 30.4% 31.2% 30.6% - Research and development expenses (17,477) (19,990) (22,786) (24,398) 7.1 (Percent of revenue) 10.8% 10.2% 11.4% 10.8% - Amortization on intangible assets associated with products (3,979) (6,205) (6,412) (6,740) 5.1 (Percent of revenue) 2.5% 3.2% 3.2% 3.0% - Other income 723 44,999 468 417 (10.9) Other expenses (458) (1,681) (728) (364) (50.0) Operating profit 35,374 80,180 32,479 38,691 19.1 (Percent of revenue) 21.9% 41.1% 16.3% 17.2% - Finance income 768 782 1,105 1,004 (9.2) Finance expenses (279) (1,492) (3,529) (434) (87.7) Profit before tax 35,863 79,470 30,055 39,261 30.6 (Percent of revenue) 22.2% 40.7% 15.1% 17.5% - Income tax expenses (11,831) (26,097) (8,331) (4,000) (52.0) Net profit for the year 24,032 53,373 21,724 35,261 62.3 (Percent of revenue) 14.9% 27.3% 10.9% 15.7% - ROE (%) 12.0 22.6 8.4 13.0 - (Core basis) Year ended March 31 2015 2016 2017 2018 % Change 2018/2017 Revenue 161,831 195,291 199,096 224,942 13.0 Cost of sales (56,373) (72,879) (74,966) (86,378) 15.2 (Percent of revenue) 34.8% 37.3% 37.7% 38.4% - Gross profit 105,458 122,463 124,130 138,564 11.6 (Percent of revenue) 65.2% 62.7% 62.3% 61.6% - Selling, general and administrative expenses (48,893) (59,406) (61,657) (68,788) 10.6 (Percent of revenue) 30.2% 30.4% 31.0% 30.6% - Research and development expenses (17,477) (19,990) (22,786) (24,398) 7.1 (Percent of revenue) 10.8% 10.2% 11.4% 10.8% - Operating profit 39,088 43,067 39,687 45,378 14.3 (Percent of revenue) 24.2% 22.1% 19.9% 20.2% - Profit before tax 39,088 43,067 39,687 45,378 14.3 (Percent of revenue) 24.2% 22.1% 19.9% 20.2% - Income tax expenses (13,140) (13,904) (10,562) (11,920) 12.9 Net profit for the year 25,948 29,163 29,125 33,458 14.9 (Percent of revenue) 16.0% 14.9% 14.6% 14.9% - ROE (%) 13.0 12.4 11.3 12.4 - - 4 -
Consolidated statements of income and comprehensive income Year ended March 31 2014* 2014 [12month] 2015 % Change 2016/2015 Net sales 148,663 146,013 161,881 10.9 Cost of sales 58,104 57,171 56,423 (1.3) (Percent of net sales) 39.1% 39.2% 34.9% - Gross profit 90,558 88,842 105,458 18.7 (Percent of net sales) 60.9% 60.8% 65.1% - Selling, general and administrative expenses 63,144 60,006 71,942 19.9 (Percent of net sales) 42.5% 41.1% 44.4% - R&D expenditures 19,040 18,235 18,062 (0.9) (Percent of net sales) 12.8% 12.5% 11.2% - Operating income 27,414 28,835 33,516 16.2 (Percent of net sales) 18.4% 19.7% 20.7% - Non-operating income 975 952 1,333 40.0 Non-operating expenses 465 455 333 (26.8) Ordinary income 27,924 29,332 34,516 17.7 (Percent of net sales) 18.8% 20.1% 21.3% - Extraordinary gain 473 473 155 (67.2) Extraordinary loss 1,504 1,014 344 (66.1) Income before income taxes 26,893 28,792 34,327 19.2 (Percent of net sales) 18.1% 19.7% 21.2% - Income taxes - current 11,762 11,255 12,600 12.0 Income taxes - deferred (1,978) (1,385) (843) (39.1) Income before minority interests 17,109 18,922 22,570 19.3 Net income 17,109 18,922 22,570 19.3 (Percent of net sales) 11.5% 13.0% 13.9% - Income before minority interests 17,109 18,922 22,570 19.3 Other comprehensive income 8,269 10,188 8,708 (14.5) Comprehensive income 25,378 29,111 31,278 7.4-5 -
Net sales/revenue details Net sales/revenue by business segment Year ended March 31 2014* 2014 [12month] 2015 2016 2017 2018 % Change Prescription pharmaceuticals 139,257 136,610 152,556 181,550 183,469 206,967 12.8% 214,716 Ophthalmics 127,395 124,790 136,059 172,545 181,859 205,868 13.2% 213,572 Anti-rheumatics 10,251 10,251 9,629 3,495 - - - - Other pharmaceuticals 1,610 1,569 6,868 5,510 1,610 1,099 (31.1)% 1,144 OTC pharmaceuticals 6,455 6,453 6,706 11,004 12,553 14,594 16.3% 16,498 Medical devices 2,678 2,678 2,313 2,394 2,536 2,583 1.8% 2,953 Others 272 272 256 343 537 798 48.6% 2,833 Total net sales/revenue 148,663 146,013 161,831 195,291 199,096 224,942 13.0% 237,000 [Japan] Year ended March 31 2014* 2014 [12month] 2015 2016 2017 2018 % Change Prescription pharmaceuticals 112,798 112,767 115,672 128,278 130,018 141,067 8.5% 139,755 Ophthalmics 101,779 101,779 105,345 124,165 129,594 140,415 8.3% 139,439 Anti-rheumatics 10,162 10,162 9,568 3,495 - - - - Other pharmaceuticals 856 825 759 617 424 653 59.1% 315 OTC pharmaceuticals 6,417 6,417 6,638 10,918 12,421 14,301 15.1% 16,144 Medical devices 2,625 2,625 2,269 2,323 2,514 2,527 0.5% 2,746 Others 272 272 256 330 404 758 87.4% 2,652 Total net sales/revenue 122,113 122,082 124,835 141,849 145,358 158,653 9.1% 161,296 (Japan sales/total sales) 82.1% 83.6% 77.1% 72.6% 73.0% 70.5% - 68.1% [Overseas] Year ended March 31 2014* 2014 [12month] 2015 2016 2017 2018 % Change Prescription pharmaceuticals 26,459 23,843 36,884 53,271 53,451 65,900 23.3% 74,962 Ophthalmics 25,616 23,010 30,714 48,379 52,265 65,453 25.2% 74,132 Anti-rheumatics 88 88 61 - - - - - Other pharmaceuticals 754 743 6,109 4,892 1,186 447 (62.3)% 829 OTC pharmaceuticals 37 35 67 87 132 293 121.8% 355 Medical devices 52 52 44 71 22 56 153.6% 207 Others - - - 13 132 40 (69.8)% 181 Total net sales/revenue 26,550 23,931 36,995 53,442 53,738 66,289 23.4% 75,704 (Overseas sales/total sales) 17.9% 16.4% 22.9% 27.4% 27.0% 29.5% - 31.9% Overseas net sales/revenue by region Year ended March 31 2014* 2014 2015 2016 2017 2017 % Change North America 1,073 1,016 6,169 5,265 1,433 371 (74.1)% 476 EMEA #1 12,302 11,527 14,377 25,674 28,657 35,015 22.2% 39,093 Asia 13,173 11,645 16,450 22,504 23,647 30,903 30.7% 36,134 Total overseas net sales/revenue 26,550 24,188 36,995 53,442 53,738 66,289 23.4% 75,704 Overseas profit contribution Year ended March 31-2014 2015 2016 2017 2018 % Change North America - (1,662) (2,033) (2,197) (3,424) (4,627) 35.1% (4,523) EMEA #1 - (81) (734) 4,781 3,514 5,980 70.2% 8,794 Asia - 1,087 3,181 5,088 4,912 7,334 49.3% 9,565 Total overseas profit - (656) 414 7,672 5,001 8,686 73.7% 13,836 #1 Europe, the Middle East and Africa - 6 -
Net sales/revenue details Net sales/revenue of major pharmaceuticals Brand name Generic name/formulation Cravit levofloxacin/ophthalmic solution Tarivid ofloxacin/ophthalmic solution Tapcom tafluprost-timolol maleate/ combination ophthalmic solution Tapros tafluprost/ophthalmic solution Cosopt dorzolamide hydrochloride-timolol maleate/combination ophthalmic solution Timoptol timolol maleate/ ophthalmic solution Timoptol XE timolol maleate/ long-acting ophthalmic solution Trusopt dorzolamide hydrochloride/ ophthalmic solution Rescula isopropyl unoprostone/ ophthalmic solution Alesion epinastine hydrochloride/ ophthalmic solution Flumetholon fluorometholone/ ophthalmic solution Kary Uni pirenoxine/ ophthalmic solution Oftan Catachrom cytochrome C, adenosine, nicotinamide/ ophthalmic solution Opegan Hi sodium hyaluronate/ adjuvant for ophthalmic operations Eylea aflibercept/ soulution for intravitreal injection Therapeutic category Bacterial conjunctivitis Bacterial conjunctivitis Glaucoma Glaucoma Glaucoma Glaucoma Glaucoma Glaucoma Glaucoma Allergy Inflammation Senile cataract Senile cataract Adjuvant for ophthalmic operations Intravitreal VEGF inhibitor Region 2014* 2014 2015 2016 2017 2018 % Change 2017/2016 Total 14,210 13,584 13,399 14,250 12,884 14,944 16.0 15,443 Japan 8,175 8,175 6,498 5,918 4,660 4,105 (11.9) 3,415 Asia 4,670 4,139 5,423 7,001 6,980 9,225 32.2 10,154 EMEA 1,364 1,267 1,478 1,331 1,245 1,614 29.7 1,874 Total 2,040 1,924 1,910 1,761 1,541 1,581 2.6 1,467 Japan 955 955 762 673 559 508 (9.2) 418 Asia 1,085 969 1,147 1,088 982 1,073 9.3 1,049 Total - - 381 1,534 2,798 3,892 39.1 4,880 Japan - - 342 1,381 2,256 2,479 9.9 2,454 Asia - - - - 38 158 317.6 219 EMEA - - 39 153 504 1,255 148.8 2,208 Total 12,731 12,516 12,330 15,633 16,406 17,844 8.8 18,883 Japan 8,957 8,957 8,329 9,168 9,592 9,610 0.2 9,686 Asia 553 520 817 1,097 1,227 1,807 47.3 2,026 EMEA 3,221 3,040 3,185 5,368 5,587 6,427 15.0 7,171 Total 11,846 11,846 12,478 20,583 22,164 24,200 9.2 21,202 Japan 11,846 11,846 10,689 11,214 11,366 11,403 0.3 8,957 Asia - - 892 2,493 2,669 3,197 19.8 3,317 EMEA - - 897 6,876 8,128 9,600 18.1 8,928 Total 1,185 1,185 1,267 1,930 1,509 1,451 (3.8) 990 Japan 1,185 1,185 1,216 1,182 967 787 (18.7) 470 Asia - - 29 140 119 116 (2.7) 112 EMEA - - 22 608 422 548 30.1 408 Total 1,931 1,931 1,984 2,463 2,382 2,221 (6.8) 1,976 Japan 1,931 1,931 1,918 1,886 1,614 1,407 (12.9) 1,203 Asia - - 27 87 88 105 19.1 109 EMEA - - 39 489 679 709 4.4 664 Total - - 1,853 4,561 4,343 4,677 7.7 4,547 Japan - - 1,545 2,125 1,731 1,641 (5.2) 1,446 Asia - - 55 446 271 327 20.9 462 EMEA - - 252 1,990 2,342 2,709 15.7 2,639 Total 2,147 2,147 1,935 1,845 1,633 1,467 (10.1) 1,256 Japan 2,147 2,147 1,935 1,845 1,633 1,467 (10.1) 1,256 Total 2,103 2,103 6,698 9,483 12,235 16,851 37.7 17,727 Japan 2,103 2,103 6,698 9,483 12,235 16,851 37.7 17,727 Total 3,973 3,899 3,811 3,775 3,347 3,497 4.5 3,141 Japan 3,075 3,075 2,844 2,655 2,224 2,113 (5.0) 1,652 Asia 898 823 967 1,120 1,123 1,385 23.2 1,490 Total 4,060 3,978 3,909 4,187 4,124 4,413 7.0 4,398 Japan 3,162 3,162 2,908 2,900 2,833 2,741 (3.2) 2,644 Asia 898 816 1,001 1,287 1,291 1,672 29.6 1,755 Total - 1,605 1,850 1,870 2,224 2,695 21.2 2,800 EMEA - 1,605 1,850 1,870 2,224 2,695 21.2 2,800 Total 2,868 2,868 2,574 2,568 2,285 2,304 0.8 2,109 Japan 2,868 2,868 2,574 2,568 2,285 2,304 0.8 2,109 Total 18,757 18,757 24,886 39,988 45,155 51,517 14.1 54,473 Japan 18,757 18,757 24,886 39,988 45,155 51,517 14.1 54,473 Total 21,823 21,416 19,611 19,864 17,595 18,170 3.3 17,708 Hyalein sodium hyaluronate/ophthalmic solution Dry eye Japan 18,179 18,179 15,316 14,491 11,852 10,772 (9.1) 8,541 Asia 3,645 3,237 4,295 5,372 5,743 7,397 28.8 9,167 Total 7,938 7,938 7,895 9,631 11,940 14,286 19.6 16,087 Diquas Dry eye Japan 7,831 7,831 7,419 8,880 11,016 12,822 16.4 14,463 diquafosol sodium/ophthalmic solution Asia 106 107 476 751 924 1,463 58.3 1,625 Ikervis ciclosporin/ophthalmic solution Cationorm OTC pharmaceuticals Dry eye Dry eye Total - - - 751 1,303 2,049 57.2 2,880 Asia - - - - 2 68-327 EMEA - - - 751 1,301 1,981 52.2 2,553 Total - 473 819 1,453 1,835 2,092 14.0 3,116 Asia - - 5 69 116 199 72.3 173 EMEA - 383 671 1,141 1,439 1,670 16.1 2,713 North - 91 143 242 280 223 (20.4) 230 America Total 6,455 6,440 6,705 11,004 12,553 14,594 16.3 16,498 Japan 6,418 6,404 6,638 10,918 12,421 14,301 15.1 16,144 Asia 38 36 67 87 132 293 121.8 355 Year ended March 31 2014* 2014 2015 2016 2017 2018 Exchange rates : US dollar 100.04 100.04 110.14 120.45 108.64 110.94 110.00 : Euro 132.98 132.34 139.01 132.46 118.96 129.92 130.00 : CNY 15.93 15.72 17.84 19.05 16.14 16.84 17.00 Nots: s in this report are based on the currently available information. Actual results may differ materially depending on a number of factors including adverse economic conditions, etc. (Yen) - 7 -
Consolidated statement of financial position Year ended March 31 2015 2016 2017 2018 % % % % Assets Non-current assets Property, plant and equipment 29,104 9.6 27,991 7.9 28,550 8.0 29,706 7.6 Intangible assets 84,433 27.8 83,681 23.5 138,935 38.7 134,495 34.6 Financial assets 34,725 11.4 44,535 12.5 29,889 8.3 35,775 9.2 Deferred tax assets 2,978 1.0 2,345 0.7 2,396 0.7 2,264 0.6 Other non-current assets 2,288 0.8 2,109 0.6 2,124 0.6 2,855 0.7 Total non-current assets 153,528 50.5 160,660 45.2 201,894 56.3 205,095 52.8 Current assets Inventories 20,133 6.6 24,996 7.0 28,502 7.9 30,636 7.9 Trade and other receivables 61,701 20.3 65,998 18.6 70,970 19.8 78,654 20.2 Other financial assets 187 0.1 234 0.1 333 0.1 472 0.1 Other current assets 2,728 0.9 3,714 1.0 3,909 1.1 4,322 1.1 Cash and cash equivalents 65,923 21.7 99,798 28.1 53,297 14.8 69,283 17.8 Total current assets 150,672 49.5 194,739 54.8 157,011 43.7 183,367 47.2 Total assets 304,200 100.0 355,399 100.0 358,906 100.0 388,463 100.0 Equity and liabilities Equity Share capital 7,383 2.4 7,695 2.2 7,792 2.2 8,032 2.1 Capital surplus 8,077 2.7 8,389 2.4 8,417 2.3 8,657 2.2 Treasury shares (18) (0.0) (24) (0.0) (10) (0.0) (11) (0.0) Retained earnings 178,840 58.8 221,945 62.4 223,283 62.2 249,225 64.2 Other components of equity 17,497 5.8 22,003 6.2 15,628 4.4 19,921 5.1 Total equity attributable to owners 211,779 69.6 260,009 73.2 255,110 71.1 285,823 73.6 of the company Non-controlling interests - - - - 819 0.2 1,734 0.4 Total equity 211,779 69.6 260,009 73.2 255,929 71.3 287,557 74.0 Liabilities Non-current liabilities Financial liabilities 25,351 8.3 12,944 3.6 26,288 7.3 21,244 5.5 Net defined benefit liabilities 5,459 1.8 2,556 0.7 1,900 0.5 1,804 0.5 Provisions 1,444 0.5 1,629 0.5 1,426 0.4 1,367 0.4 Deferred tax liabilities 2,874 0.9 3,988 1.1 17,963 5.0 12,909 3.3 Other non-current liabilities 953 0.3 1,043 0.3 1,919 0.5 1,380 0.4 Total non-current liabilities 36,081 11.9 22,161 6.2 49,496 13.8 38,704 10.0 Current liabilities Trade and other payables 20,250 6.7 24,504 6.9 23,937 6.7 29,743 7.7 Other financial liabilities 19,298 6.3 19,881 5.6 17,649 4.9 14,404 3.7 Income tax payable 6,729 2.2 20,431 5.7 3,279 0.9 7,656 2.0 Provisions 1,197 0.4 1,276 0.4 1,372 0.4 1,508 0.4 Other current liabilities 8,866 2.9 7,138 2.0 7,244 2.0 8,890 2.3 Total current liabilities 56,340 18.5 73,230 20.6 53,481 14.9 62,201 16.0 Total liabilities 92,421 30.4 95,391 26.8 102,977 28.7 100,905 26.0 Total equity and liabilities 304,200 100.0 355,399 100.0 358,906 100.0 388,463 100.0-8 -
Consolidated statements of cash flows Year ended March 31 2015 2016 2017 2018 Ⅰ. Cash flows from operating activities: Net profit for the year 24,032 53,373 21,724 35,261 Depreciation and amortization 6,958 9,338 9,882 10,896 Impairment losses 290 395 475 150 Finance income and expenses (529) (545) 983 (327) Income tax expenses 11,831 26,097 8,331 4,000 Gain on disposal of disposal groups - (44,477) - - Decrease (increase) in trade and other receivables (7,701) (4,799) (5,489) (7,116) Decrease (increase) in inventories (521) (5,388) (4,120) (1,435) Increase (decrease) in trade and other payables 1,251 4,376 (425) 5,697 Increase (decrease) on net defined benefit liabilities 761 (3,974) (200) 285 Other 2,554 653 2,877 1,706 Subtotal 38,926 35,049 34,039 49,117 Interest received 81 67 74 145 Dividends received 548 573 681 598 Interest paid (82) (98) (52) (27) Income tax paid (14,087) (13,067) (23,900) (6,990) Net cash flows from (used in) operating activities 25,386 22,525 10,843 42,843 Ⅱ. Cash flows from investing activities: Payments into time deposits (84) (21) - - Proceeds from withdrawal of time deposits 184 21 19 - Payments for acquisition of investments (114) (2,210) (478) (565) Proceeds from sale and redemption of investments 4,149 2,682 1,364 2,879 Increase (decrease) through acquisition of subsidiary - - (19,064) - Payments for acquisition of property, plant and equipment (2,972) (4,299) (4,145) (3,984) Proceeds from sales of property, plant and equipment 656 696 4 - Payments for acquisition of intangible assets (63,468) (4,793) (5,355) (5,953) Proceeds on disposal of disposal groups - 45,000 - - Other (60) (25) (545) (636) Net cash flows from (used in) investing activities (61,709) 37,052 (28,201) (8,259) Ⅲ. Cash flows from financing activities: Proceeds from short-term loans payable 35,000 - - - Repayments of short-term loans payable (35,000) - - - Proceeds from long-term loans payable 40,000 500 3,000 - Repayments of long-term loans payable (2,970) (15,133) (9,524) (8,316) Acquisition of treasury shares - - (12,380) (1) Proceeds from contributions of non-controlling interests - - 832 838 Dividends paid (8,264) (9,923) (10,751) (10,559) Other 194 489 167 408 Net cash flows from (used in) financing activities 28,960 (24,066) (28,657) (17,631) Ⅳ. Net increase (decrease) in cash and cash equivalents (7,363) 35,510 (46,015) 16,953 Ⅴ. Cash and cash equivalents at the beginning of year 72,397 65,923 99,798 52,282 Ⅵ. Effect of exchange rate changes on cash and cash equivalents 889 (1,636) (1,501) 48 Ⅶ. Cash and cash equivalents at the end of period 65,923 99,798 52,282 69,283-9 -
Other consolidated information R&D expenses Year ended March 31 2014* 2015 2016 2017 2018 Consolidated 19,040 17,477 19,990 22,786 24,398 25,000 Percent of net sales/revenue 12.8% 10.8% 10.2% 11.4% 10.8% 10.5% Capital expenditures Year ended March 31 2014* 2015 2016 2017 2018 Consolidated 3,155 5,383 4,474 5,216 5,445 7,480 Depreciation and amortization Year ended March 31 2014* 2015 2016 2017 2018 Manufacturing cost 1,330 1,446 1,445 1,515 1,950 2,040 Selling, general and administrative expenses 648 864 1,035 1,246 1,453 1,520 R&D expenses 634 668 653 709 752 700 Consolidated total 2,612 2,979 3,133 3,470 4,155 4,260 Note: Excluding amortization of intangible assets and long-term advance expense Amortization on intangible assets associated with products Year ended March 31 2014* 2015 2016 2017 2018 Intangible assets (Merck products) - 3,734 5,186 5,357 5,592 5,810 Intangible assets (Ikervis) - - 625 674 736 740 Other - 245 394 381 412 380 Consolidated total - 3,979 6,205 6,412 6,740 6,930 Additional information of statement of financial position Year ended March 31 2014* 2015 2016 2017 2018 In-process research and development - 16,145 11,363 54,818 54,311 Investment securities 21,739 33,634 43,413 28,615 34,713 Inventories 20,031 20,133 24,996 28,502 30,636 Notes and accounts receivable 52,086 59,611 63,954 68,829 76,318 Notes and accounts payable #1 14,270 14,330 17,225 17,883 22,471 #1 Including electronically recorded monetary liabilities Number of employees Year ended March 31 2014* 2015 2016 2017 2018 Japan 1,903 1,923 1,915 1,975 2,015 North America 154 162 175 213 232 EMEA #2 530 588 660 669 651 Asia 485 557 713 810 907 Consolidated 3,072 3,230 3,463 3,667 3,805 #2 Europe, the Middle East and Africa - 10 -
Research & development Pipeline of prescription pharmaceuticals (clinical stage) As of May 9, 2018 Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched Merck Sharp & diquafosol sodium DE-089 Dry eye Dohme Corp. (U.S.) China Oct-17 A dry eye treatment which stimulates secretion of mucin and aqueous components from the corneal and conjunctival epithelium. Its mechanism of action is different from existing treatments. Launched in December 2010 in Japan. Acquired import drug license in China in October 2017. Launched in October 2013 in Korea. Launched in Vietnam in February 2016. Launched in Thailand in April 2016. Currently seeking sequential approvals for marketing in Asia. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched sirolimus DE-109 Uveitis Original U.S. Japan Europe An intravitreal injection with immunosuppressive effect, anti-angiogenic effect, etc. Planning an additional clinical trial in the U.S. NDA filed in Asia in April 2015. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched epinastine Nippon Boehringer DE-114A Allergic conjunctivitis Japan hydrochloride Ingelheim An H₁ receptor antagonist with membrane-stabilizing function, as treatment for allergic conjunctivitis. High dose drug. Started Phase 3 in Japan in May 2017. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched U.S. omidenepag Glaucoma/ Co-development DE-117 Japan Nov-17 isopropyl Ocular hypertension with Ube Industries Asia An EP2 receptor agonist with a new mechanism of action. Completed Phase 2b in the U.S. in February 2015. Filed for manufacturing and marketing approval in Japan in November 2017. Started Phase 3 in Asia in December 2016. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched Wet Age-related TRACON carotuximab DE-122 U.S. (Phase 2a) macular degeneration Pharmaceuticals An intravitreal injection of anti-endoglin antibody. Started Phase 2a in July 2017 for development in the U.S. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched Glaucoma/ ONO U.S. (Phase 2b) sepetaprost DE-126 Ocular hypertension PHARMACEUTICAL Japan (Phase 2b) A prostaglandin analogue eye drop drug product with a novel mode of action that is both FP and EP3 receptors dual agonist for the treatment of glaucoma and ocular hypertension. Started Phase 2b in the U.S. and Japan in July 2017. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched atropine sulfate DE-127 Myopia Singapore Health Services, Nanyang Technological University Muscarinic antagonist which reduces juvenile myopia progression. Started Phase 2 in Asia in November 2017. Asia Asia Apr-15 - Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched - DE-128 (InnFocus Glaucoma Original U.S. (Phase 2/3) MicroShunt) Europe In August 2016, acquired InnFocus, developer of InnFocus MicroShunt. MicroShunt is a drainage implant device designed to lower and sustain intraocular pressure (IOP) for the treatment of primary open-angle glaucoma through the drainage of aqueous humor. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched DE-076B Severe keratitis in U.S. ciclosporin Original (Cyclokat) patients with dry eye Asia Dec-17 An ophthalmic emulsion to treat severe keratitis in adult patients with dry eye through an immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue absorption. Launched in Germany and England in July 2015 with successive launches following in European countries. Currently seeking sequential approvals for marketing in Asia and launched in Thailand in December 2017. Received a Notice of Non-compliance (NON) from Health Canada in April 2018. - 11 -
Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched DE-076C Vernal ciclosporin Original Europe Dec-16 (Vekacia) Keratoconjunctivitis An ophthalmic emulsion which improves vernal keratoconjunctivitis by immunosuppressive effect. Cationic emulsion technology has enhanced ocular tissue absorption. NDA filed and granted Priority Review status in Europe in December 2016. In July 2017, the Committee for Human Medicinal Products of the European Medicines Agency adopted a positive opinion, recommending the marketing authorization. Generic name Dev. code Indication Original/Licensor Region P1 P2 P3 NDA Filed Approved Launched DE-130A Glaucoma/ latanoprost Original Europe (Catioprost) Ocular hypertension An ophthalmic emulsion of a prostaglandin F2α derivative, for the treatment of glaucoma and ocular hypertension. Changes from Q3 FY17 (February 6, 2018) Dev. Code Changes DE-076B (Cyclokat) Received a Notice of Non-compliance (NON) from Health Canada in April 2018. - 12 -
Pharmaceutical market in Japan Revision of National Health Insurance (NHI) drug prices 2009 2010 2011 2012 2013 2014 2015 2016 #1 2017 2018 Industry average - mid -6% - -6.25% - -2.7% - -5.57% #1 - -7.48% Ophthalmic drugs - early -3% - mid -4% - high -1% - early -6% - mid -5% Santen - mid -5% - high -5% - high -1% - early -7% #2 - mid -4% (Compiled by Santen) #1 Excluding market expansion re-pricing -0.9% #2 Mid -4% price cut in 2016 excluding its impact of Eylea Revision of NHI drug prices: In Japan, drug prices are generally revised every two years to reflect their market price. The drugs marketed at lower market prices will bear larger reduction margins at the revision. Market shares in prescription ophthalmics Excluding consumption tax impact 2014 Industry average -5.6% Ophthalmic drugs high -4% Santen high -4% (Billions of yen) Year ended March 31 2014 2015 2016 2017 2018 Share 39.4% 40.1% 44.0% 45.5% 46.2% Market 301.3 323.7 347.5 345.5 363.3 Source: Copyright 2018 IQVIA. Notes: On an NHI drug price basis. IMS-JPM 2013.4-18.3; Santen analysis based on IQVIA data. Reprinted with permission Market shares by therapeutic area - prescription ophthalmics # Source: Copyright 2018 IQVIA. IMS-JPM 2013.4-18.3; Santen analysis based on IQVIA data. Reprinted with permission (Billions of yen) Year ended March 31 2014 2015 2016 2017 2018 Glaucoma treatments Share 30.5% 32.1% 32.6% 32.2% 31.2% Market 104.7 105.7 112.6 114.3 114.9 Corneal disease Share 70.5% 65.6% 63.4% 62.7% 62.2% treatments Market 44.2 44.2 46.4 45.5 46.6 Anti-infective Share 58.5% 54.0% 49.8% 44.1% 40.0% Market 18.3 16.8 16.4 14.6 13.9 Anti-allergy Share 21.2% 32.0% 36.3% 42.9% 47.9% Market 27.9 33.9 35.8 37.7 42.9 Anti-VEGF Share 48.7% 48.8% 65.7% 72.4% 71.8% Market 43.2 61.6 74.5 74.5 85.3 Notes: On an NHI drug price basis. *Including co-promoted product of Bayer Yakuhin, Ltd. (MAH) (Anti-VEGF Eylea) Source: Copyright 2018 IQVIA. IMS-JPM 2013.4-18.3; Santen analysis based on IQVIA data. Reprinted with permission. - 13 -
Stock information Stock price (Tokyo Securities Exchange 1st market) (Yen and thousand shares) Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Jan-18 Feb-18 Mar-18 Stock price: End of month 1,567 1,525 1,524 1,557 1,706 1,773 1,799 1,712 1,771 1,781 1,720 1,715 Volume 39,666 38,446 33,846 24,796 25,667 24,556 24,350 27,355 30,660 20,312 23,774 25,095 Major shareholders (top 10) As of March 31, 2018 Name Number of shares held Percent of investment Thousand shares % State Street Bank and Trust Company 505223 33,702 8.3 Japan Trustee Service Bank, Ltd.(Trust Account) 31,688 7.8 The Master Trust Bank of Japan, Ltd.(Trust Account) 22,288 5.5 RBC IST 15 PCT Lending Account - Client Account 11,280 2.8 Nippon Life Insurance Company 10,662 2.6 The Bank of Tokyo-Mitsubishi UFJ, Ltd. 10,605 2.6 ONO PHARMACEUTICAL Co.,Ltd. 9,307 2.3 Development Bank of Japan Inc. 8,275 2.0 State Street Bank West Client - Treaty 505234 7,534 1.9 Japan Trustee Service Bank, Ltd.(Trust Account 5) 7,232 1.8 Major stock information Year ended March 31 2014 2015 2016 2017 2018 Issued shares (thousands) 82,582 82,653 414,192 406,173 406,848 Treasury stock (thousands) 2 3 22 7 7 Market Capitalization (million) 378,219 723,181 701,188 654,740 697,731 A purchased amount of money (millions of yen) - - - 12,310 - The number of the purchased stocks (thousand shares) - - - 8,284 - Notes: The Company has conducted a 5-for-1 stock split with an effective date of April 1, 2015. - 14 -
Stock information Breakdown of shareholding by number of shares Year ended March 31 2014 2015 2016 # 2017 2018 Thousand shares Proportion (%) Thousand shares Proportion (%) Thousand shares Proportion (%) Thousand shares Proportion (%) Thousand shares Proportion (%) Financial institutions 28,971 35.1 30,049 36.4 146,963 35.5 152,090 37.4 148,006 36.4 City & regional banks 2,270 2.8 2,262 2.7 11,576 2.8 11,496 2.8 11,566 2.8 Trust banks 17,581 21.3 18,726 22.7 98,601 23.8 103,541 25.5 105,060 25.8 (concerned in trust works) 15,192-16,333-86,474-90,732-93,483 - Life and non-life insurance 4,290 5.2 4,196 5.1 21,016 5.1 21,455 5.3 15,810 3.9 Other financial institutions 4,829 5.8 4,862 5.9 15,770 3.8 15,599 3.8 15,570 3.8 Securities firms 721 0.9 922 1.1 4,868 1.2 4,915 1.2 4,536 1.1 Other institutions 7,913 9.6 7,880 9.5 36,938 8.9 34,231 8.4 31,319 7.7 Foreign investors 37,597 45.5 36,373 44.0 186,294 45.0 175,774 43.3 187,543 46.1 Individual investors 7,376 8.9 7,423 9.0 39,106 9.4 39,156 9.6 35,436 8.7 Treasury Stock 2 0.0 3 0.0 22 0.0 7 0.0 7 0.0 Total 82,582 100.0 82,653 100.0 414,192 100.0 406,173 100.0 406,848 100.0 Notes: The Company has conducted a 5-for-1 stock split with an effective date of April 1, 2015. Breakdown of shareholding by number of shareholders Year ended March 31 2014 2015 2016 2017 2018 Number of Proporshareholders tion (%) Number of shareholders Proportion (%) Number of shareholders Proportion (%) Number of shareholders Proportion (%) Number of shareholders Proportion (%) Financial institutions 56 0.8 62 0.6 77 0.3 66 0.3 68 0.3 City & regional banks 5 0.1 4 0.1 8 0.0 7 0.0 9 0.0 Trust banks 25 0.3 27 0.2 30 0.1 26 0.1 26 0.1 Life and non-life insurance 21 0.3 23 0.2 27 0.1 24 0.1 23 0.1 Other financial institutions 5 0.1 8 0.1 12 0.1 9 0.1 10 0.1 Securities firms 35 0.4 33 0.3 52 0.2 40 0.2 42 0.2 Other institutions 114 1.5 122 1.1 154 0.7 152 0.6 130 0.7 Foreign investors 407 5.2 486 4.2 549 2.3 539 2.3 593 3.0 Individual investors 7,167 92.1 10,664 93.8 22,700 96.5 22,852 96.6 19,051 95.8 Treasury stock 1 0.0 1 0.0 1 0.0 1 0.0 1 0.0 Total 7,780 100.0 11,368 100.0 23,533 100.0 23,650 100.0 19,885 100.0-15 -
Consolidated subsidiaries Japan As of March 31,2018 Company name Main business Location Paid-in capital Equity owned Claire Co., Ltd. Cleaning of antidust and sterilized clothing Japan 90 million yen 100% Santen Business Services Co., Ltd. Support of indirect operations Japan 10 million yen 100% Santen Eye Care Co., Ltd. Production and marketing of pharmaceuticals Japan 10 million yen 100% North America Company name Main business Location Paid-in capital Equity owned Santen Holdings U.S. Inc. Santen Inc. Advanced Vision Science, Inc. InnFocus, Inc. Holding company for North American businesses Clinical development and business development of pharmaceuticals Development, production and marketing of medical devices Development, production of devices for glaucoma U.S.A. U.S.A. 24,784 thousand US$ 8,765 thousand US$ 100% 100% #1 U.S.A. 10 thousand US$ 100% #1 U.S.A. 2 thousand US$ 100% Santen Ventures, Inc. Investment in ventures U.S.A. 10 thousand US$ 100% #1 EMEA Company name Main business Location Paid-in capital Equity owned Santen Holdings EU B.V. Santen Oy Santen S.A.S. Santen GmbH Holdings company for EMEA business operation Clinical development, contract manufacturing, production and marketing of pharmaceuticals Clinical development and marketing of pharmaceuticals Marketing of pharmaceuticals and business development Netherlands 50 thousand euros 100% Finland France 20,000 thousand euros 1,976 thousand euros 100% #2 100% #2 Germany 25 thousand euros 100% #2 SantenPharma AB Marketing support of pharmaceuticals Sweden 500 thousand SEK 100% #2 Santen SA Headquarter of EMEA business, production and marketing of pharmaceuticals Switzerland 12,065 thousand Swiss franc 100% #2 Santen Italy S.r.l. Marketing of pharmaceuticals Italy 10 thousand euros 100% #2 2,300 thousand Santen UK Limited Marketing of pharmaceuticals UK 100% pounds #2 Santen Pharmaceutical Spain, S.L. Marketing of pharmaceuticals Spain 3 thousand euros 100% #2 SANTEN LIMITED LIABILITY COMPANY Asia Marketing support of pharmaceuticals Russia 10 thousand RUB 100% #2 Company name Main business Location Paid-in capital Equity owned Santen Pharmaceutical (China) Co., Clinical development, production and Ltd. marketing of pharmaceuticals China 3,800 million yen 100% Santen Pharmaceutical Sales and 35,000 thousand Marketing of pharmaceuticals China Marketing (Suzhou) Co., Ltd. CNY 100% #3 Chongqing Santen Kerui 200,000 thousand Production and marketing of pharmaceuticals China Pharmaceutical Co., Ltd CNY 49% #4 Santen Pharmaceutical Korea Co., Ltd. Taiwan Santen Pharmaceutical Co., Ltd. Santen India Private Limited Santen Pharmaceutical Asia Pte. Ltd. Clinical development and marketing of pharmaceuticals Marketing of pharmaceuticals Market research and clinical development of pharmaceuticals Headquarter of ASEAN business, production and marketing of pharmaceuticals Korea Taiwan India Singapore SANTEN (THAILAND) CO., LTD. Marketing of pharmaceuticals Thailand SANTEN PHARMA MALAYSIA SDN. BHD. Marketing of pharmaceuticals Malaysia SANTEN PHILIPPINES INC. Marketing of pharmaceuticals Philippines SANTEN PHARMACEUTICAL (HONG KONG) LIMITED Marketing of pharmaceuticals Hong Kong #1 Indirect investment through Santen Holdings U.S. Inc. #2 Indirect investment through Santen Holdings EU B.V. #3 Indirect investment through Santen Pharmaceutical (China) Co., Ltd. #4 Indirect investment through Santen Pharmaceutical (China) Co., Ltd., Chongqing Kerui Pharmaceutical (Group) Co., Ltd. hold 51% of share. #5 Indirect investment through Santen Pharmaceutical Asia Pte. Ltd. 29,000,000 thousand won 42,000 thousand Taiwan dollars 48,500 thousand India rupees 20,500 thousand Singapore dollars 110,000 thousand Thai baht 4,000 thousand Malaysian ringgit 43,309thousand Philippine peso 7,600 thousand HKD 100% 100% 99.9%, 0.1% #1 100% 100% #5 100% #5 100% #5 100% #5-16 -
News releases News releases during April 2017-March 2018 For details, please refer to our Website (http://www.santen.com). 2017 7-Apr Santen Announces Strategic Investment in Regenerative Patch Technologies LLC Santen announced that Santen has made an investment in Regenerative Patch Technologies LLC ( RPT ) RPT has developed proprietary technologies that can produce and subsequently deliver a monolayer of stem cell-derived retinal pigment epithelial cells on a scaffold through a minimally invasive surgical approach. 25-Apr Santen Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for Intravitreal Sirolimus (DE-109) in the Treatment of Non-Infectious Uveitis of the Posterior Segment Santen announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravitreal (IVT) sirolimus (440 µg), development code DE-109, for the treatment of non-infectious uveitis of the posterior segment (NIU-PS). The FDA has set an action date of December 24, 2017 to complete its review of the IVT sirolimus NDA, per the Prescription Drug User Fee Act (PDUFA). IVT sirolimus was granted orphan drug designation by the FDA and the European Commission (EC) in 2011. 1-May Santen to Establish a Corporate Venture Capital Fund in the United States Santen announced plans to establish a corporate venture capital fund ( fund ) to be based in Emeryville, California, United States. The purpose of the fund is to create valuable synergies with early stage companies developing differentiated technologies as ophthalmic treatments in order to enhance Santen s R&D pipeline and contribute to our goal of improving the quality of life of patients suffering from eye diseases. 18-Jul Santen Donates to Northern Kyushu Area Disaster Relief Efforts 26-Jul Santen Receives Positive CHMP Opinion in Europe for Ciclosporin eye drops for the Treatment of Paediatric Patients with Severe Vernal Keratoconjunctivitis Santen announced that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization for ciclosporin 1mg/mL eye drops, emulsion, for the treatment of severe vernal keratoconjunctivitis (VKC) in paediatric populations1. 26-Jul Santen and TRACON Announce Initiation of a Phase 2a Study of DE-122 for the Treatment of Wet Age -Related Macular Degeneration Santen and TRACON Pharmaceuticals, Inc. (NASDAQ:TCON, TRACON) today announced that Santen has initiated a Phase 2a clinical study of DE-122 in patients with wet age-related macular degeneration (AMD).The initiation of the Phase 2a study triggers a US$7 million milestone payment from Santen to TRACON. 1-Aug Santen to Grant Subscription Rights to New Shares as Stock Options for Stock-Linked Remuneration 1-Sep Notice on Details of Subscription Rights to New Shares (Stock Options for Stock-Linked Remuneration) 19-Sep Santen Selected as a Member of Dow Jones Sustainability Asia Pacific Index, an Index for Socially Responsible Investment Santen announced that Santen has been selected for the Dow Jones Sustainability Asia Pacific Index (DJSI Asia Pacific), the Asia Pacific version of the Dow Jones Sustainability Indices (DJSI), one of the world s foremost indices for socially responsible investment (SRI). - 17 -
2017 18-Oct Santen to Launch on October 18 of Sante Beautéye Contact, a New OTC Eye Drop 26-Oct Santen to Participate in UN Global Compact Santen Pharmaceutical signed the UN Global Compact (UNGC) and became a registered participant on October 23, 2017. As a member of global society, Santen intends to support and practice the ten principles of the UNGC in the four areas of human rights, labour, environment, and anti-corruption in pursuit of a sustainable society. 1-Nov Santen Announces Approval of Diquas for the Treatment of Dry Eye in China November 1, 2017, Santen Pharmaceutical received an import drug license of Diquas Ophthalmic Solution (generic name: ;; hereinafter Diquas ) for the treatment of dry eye in China on October 20, 2017. Diquas was shown to improve dry eye signs. No serious ocular or systemic adverse drug reactions were found during the clinical trials. 27-Nov Santen Files for Manufacturing and Marketing Approval of Glaucoma and Ocular Hypertension Drug Candidate DE-117 (JAN: Omidenepag Isopropyl) November 27, 2017, Santen Pharmaceutical and Ube Industries, Ltd. (hereinafter, Ube Industries) filed for manufacturing and marketing approval of glaucoma and ocular hypertension treatment DE-117 (JAN: Omidenepag Isopropyl) to the Japanese Ministry of Health, Labour and Welfare on November 22, 2017. Santen and Ube Industries entered into a license and collaboration agreement with DE-117, and codeveloped DE-117 ophthalmic solution as a treatment for glaucoma and ocular hypertension. 21-Dec Santen Receives Complete Response Letter from U.S. FDA for Intravitreal Sirolimus (DE-109) December 21, 2017, the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) for intravitreal (IVT) sirolimus (DE-109). IVT sirolimus is an investigational therapy developed as a potential treatment for adults with noninfectious uveitis of the posterior segment, a leading cause of preventable blindness in working-age adults. 2018 20-Feb Santen Announces Appointment of New President At the meeting of the Board of Directors held on February 20, 2018, Akira Kurokawa was selected as Representative Director, Chairman and Chief Executive Officer, and Shigeo Taniuchi as Representative Director, President and Chief Operating Officer. They all assumed their offices. 20-Feb Santen Awarded for Corporate Governance The Corporate Governance of the Year awards, established by the Japan Association of Corporate Directors in 2015, honors the companies which have achieved and maintained long term profitability by implementing good corporate governance with the ultimate goal of revitalizing the Japanese economy. 23-Feb Santen to Conduct a Public Awareness Campaign for Glaucoma During World Glaucoma Week March 11-17 - 18 -